China NMPA Product Recall - Angiography system

Toshiba Medical Systems, Inc., through its Chinese entity, Toshiba Medical Systems (China) Co., Ltd., initiated a voluntary Level Two recall of its angiography systems, models INFX-9000V and INFX-9000C. This action, reported to the National Medical Products Administration (NMPA) on June 5, 2017, and publicly announced on July 18, 2017, addressed a critical issue where the dose tracking system (DTS) displayed peak skin dose (PSD) values exceeding its expected measurements. This discrepancy in the optional XIDF-AWS801 component posed a potential risk during diagnostic and interventional procedures. The affected angiography systems, registered under CFDA (Imported) 2014 No. 3302978 and 2014 No. 3302980, are used for whole-body angiography and interventional treatments. The recall affected two units sold in China. The required corrective action involved Toshiba service representatives installing modified software on the customer’s systems to ensure normal operation. Toshiba committed to follow-up visits and ongoing system monitoring, with an estimated recall completion by June 30, 2017, to uphold patient safety by rectifying the inaccurate dose display.